Dokumendiregister | Terviseamet |
Viit | 11.1-2/24/1060-1 |
Registreeritud | 26.01.2024 |
Sünkroonitud | 27.03.2024 |
Liik | Sissetulev dokument |
Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
Sari | 11.1-2 Kirjavahetus Eesti turule lastavatest/kasutusele võetavatest/levitatavatest seadmetest MSA kaudu teavitamiseks |
Toimik | 11.1-2/2024 |
Juurdepääsupiirang | Avalik |
Juurdepääsupiirang | |
Adressaat | Thema RA |
Saabumis/saatmisviis | Thema RA |
Vastutaja | Maarika Ojala (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
Originaal | Ava uues aknas |
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Hello,
I’m an Italian Regulatory Affair Specialist and I’m writing to you in order to have further information about the medical device and distributor registration into the Estonian register.
Here is the question: once the distributor has made the registration and has registered the medical device, do they have an expiration date and do they need to be renewed? If the answer is positive, after how much time is the registration invalid and need to be renewed?
Thanking you in advance.
Sincerely,
Federica Sannelli
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Federica Sannelli
RAPS MEMBER: https://bcert.me/sgmmoegjl
Tel: +39 0542 643496 Fax: +39 0542 641833 |
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| THEMA S.r.l. | Via Saragat, 5 - 40026 Imola (BO) – Italy | www.thema-med.com | [email protected] |
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Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
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Selgitustaotlus | 30.01.2024 | 57 | 11.1-2/24/1060-2 | Väljaminev dokument | ta | Thema RA |